Immediate & medium-term results of balloon dilatation in native coarctation of aorta: a reasonable initial management strategy

Background Coarctation of aorta (CoA) accounts for 5–10% of all congenital heart defects. Despite >20 years of experience with balloon dilatation (BD) as an effective therapy, initial choice of procedure still remains controversial. Purpose This study was planned to identify the predictors of success of BD in native CoA and to evaluate immediate & medium-term outcomes of the same. Methods This is a retrospective analysis of all BDs done over five years in a tertiary care centre. Success was defined as residual gradient ≤20 mmHg in the absence of a serious or life-threatening complication. In view of the high pre-dilatation gradient in many patients, a strict cut-off of 20 mmHg was not considered to be clinically feasible. Clinically acceptable outcome was thus defined as reduction of gradient to ≤20 mmHg or by ≥50% of baseline, to a final value ≤30 mmHg, in the absence of a serious or life-threatening complication. Repeat intervention on follow-up was considered in patients satisfying any of these criteria: symptoms attributed to CoA, significant residual gradient (>20 mmHg) with diastolic spill on echo, LV dysfunction, or refractory hypertension. Results Of the 111 cases analysed, 85 (76.5%) were male. The mean age was 11.79±12.64 years (1 month to 57 years). Bicuspid aortic valve was the most common associated anomaly, present in 42 (38%) patients. The mean gradient fell from 53.15±22.37 mmHg to 14.83±12.24 mmHg. Overall, the procedure was successful in 83 (74.8%) patients, and clinically acceptable outcome was obtained in 97 (87.4%) patients. Success rate and clinically acceptable outcome rate in the <18 years group was 80.7% (67/83) and 92.7% (77/83) respectively. Complications were seen in 9 (8.1%) cases. There was no mortality associated with the procedure. Ascending aortic pressure ≥150 mmHg [OR 27.94; 95% CI 1.30–598.84; p<0.001], and balloon to isthmus ratio <1 [OR 9.70; 95% CI 2.18–43.02; p<0.001] were significant negative predictors for success. At median follow-up of 43.5 months, reintervention free survival rate was 79.5% (62/78) in the overall group, and 81.5% (53/65) in the <18 years age group; with most of the repeat interventions being required within the first-year of the index procedure (14/16, 87.5%). Conclusion Immediate and medium-term success rates of BD in CoA are acceptable in majority of children and adolescents. High ascending aorta pressure and inadequate balloon size are important negative predictors of successful dilatation. Considering the economic advantages and reasonable success, balloon dilatation alone can be considered as a first line management option for native coarctation of aorta. FUNDunding Acknowledgement Type of funding sources: None.

EP.FRI.828 Accidental Placement of Nasogastric Tube into the brain

The nasogastric tube (NGT) plays a very vital role in the early resuscitation of head injury patients for various reasons. Though considered a simple procedure, it can be associated with multiple dreadful complications. Our patient was a 44-year-old male, referred from a peripheral health center for further management of severe head and faciomaxillary injuries following a motor vehicular accident. On arrival at the hospital, the endotracheal tube and NGT were in situ. A computed tomography scan of the brain revealed the NGT piercing through the cribriform plate of ethmoid and coiling into the cranial cavity with pneumocephalus. The NGT was retrieved under C-arm guidance and his injuries were managed respectively. The patient was discharged after prolong hospitalization with an acceptable outcome. With this case report, we want to remind emergency health care providers to avoid this catastrophic complication of NGT insertion in a faciomaxillary trauma patient by doing it transorally. We report a novel method of safely removing NGT which has not been reported in the past.

Book Review [Mosul: Australia’s Secret War Inside the ISIS Caliphate]

This is a book review of the book by Ben McKelvey (2020), Mosul: Australia’s Secret War Inside the ISIS Caliphate, Hachette Australia. Published by - Hachette Australia (Sydney, 2020) Format - Paperback ISBN - 978-0-7336-4541-9 339 pages Reviewed by John Battersby 'Mosul: Australia’s Secret War Inside the ISIS Caliphate' looks at parallel paths in the Al Qaeda (AQ) and ISIS inspired conflicts of the 2000s. On the one hand, it looks at those who were lured by AQ and ISIS propaganda into conceiving plots in Australia (a number were caught in the Pendennis operation), while another killed a civilian employee in October 2015 and several others left Australia to fight in Iraq and Syria in the period of ISIS’s ascendency. At the same time McKelvey relates the coinciding story lines of a number of Australian special forces personnel who were deployed to Afghanistan in 2001 and after 2003 (including the mid-2010s) to Iraq. Their exploits are detailed, the rationale for their deployment and operations is given, and light is shone on the consequences for those individuals personally. It is too often the fate of those who give their loyalty and commitment to their country, to discover that their country seldom reciprocates in equal measure. The inconsequential occasional mis-demeanours by highly disciplined servicemen that offend the sensibilities of their higher commanders were punished harshly, and the enormous personal and psychological toll that inevitably falls on individuals deployed to war-zones has not been adequately addressed by Australia. Service personnel surviving war zones to commit suicide when they come home is not an acceptable outcome of these deployments.

USING A NEW HYBRID SEGMENTATION TECHNIQUE TO SEGMENT LUNAR CRATERS AND DETERMINE ITS DIAMETER

Segmentation method is the process of partition digital image into parts depending to color, texture, and intensity. There are many segmentation methods used in different fields according to the purpose of application. In this study the global thresholding and proposed hybrid method were used to segment lunar craters. Craters on Moon's surface caused by collision between Moon and celestial objects as comet, meteorite, asteroids and others. Due to the Moon has no atmosphere, the lunar surface covered by a huge number of craters different in their size and depth depending on velocity and size of collided objects. The study of lunar craters provide information about the age and geology of a Moon's surface. So, we proposed a novel hybrid segmentation method to segment Moon's images and isolate lunar craters from other surface features and then determine the diameter of lunar craters. The proposed hybrid method combine the performance of K-Means and SFFNN together. The results shown that, the proposed method gives very acceptable outcome, where the boundaries of lunar craters were delineate in professional way that lead to accurate determination of its diameters.

Radiation Therapy for Breast Cancer: Re-Treatment

Radiation therapy is an established form of therapy for breast cancer, often applied in an adjuvant setting delivered in a post-operative environment to volumes including the breast, surgical cavity, and regional lymph nodes when appropriate. Historically, radiation therapy has not been considered an option for care when the patient recurs with the disease despite being treated with radiation therapy in the adjuvant setting. However, there can be clinical circumstances that require a different approach to the care including comprehensive re-treatment with radiation therapy in highly selected situations. This paper reviewed two patients with clinical circumstances requiring consideration for re-treatment with radiation therapy and were successfully re-treated with an acceptable outcome.

Superior oblique split tendon elongation for Brown’s syndrome: Long-term outcomes

Purpose:To report the outcomes of superior oblique split tendon elongation in Brown’s syndrome.Methods:Charts of 17 consecutive Brown’s syndrome patients who underwent superior oblique split tendon elongation were reviewed and clinical data regarding preoperative, intraoperative, and postoperative data were collected.Results:About 17 eyes of 17 children with congenital Brown’s syndrome underwent superior oblique split tendon elongation between January 2012 and March 2020 by a single surgeon. Mean age at surgery was 5.47 ± 2.82 (range 1.50–13.2). Eight (47.1%) were female. Preoperative deficit of elevation in adduction was −4 in all children. At the end of surgery, all eyes were freely elevated on adduction, on forced duction test. Mean follow-up time of 26.24 ± 11.22 (range 11–53) months. In 15 of 17 children (88.2%), motility improved, orthotropia in primary position was achieved, and head posture eliminated ( p < 0.001). Superior oblique palsy occurred in two children, who after reoperation, achieved an acceptable outcome. No intraoperative complications were recorded.Conclusion:The superior oblique split tendon elongation procedure is a useful surgical technique with stable and satisfying outcomes for the treatment of severe congenital Brown’s syndrome.

Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!

Background The current CONSORT guidelines for reporting pilot trials do not recommend hypothesis testing of clinical outcomes on the basis that a pilot trial is under-powered to detect such differences and this is the aim of the main trial. It states that primary evaluation should focus on descriptive analysis of feasibility/process outcomes (e.g. recruitment, adherence, treatment fidelity). Whilst the argument for not testing clinical outcomes is justifiable, the same does not necessarily apply to feasibility/process outcomes, where differences may be large and detectable with small samples. Moreover, there remains much ambiguity around sample size for pilot trials. Methods Many pilot trials adopt a ‘traffic light’ system for evaluating progression to the main trial determined by a set of criteria set up a priori. We construct a hypothesis testing approach for binary feasibility outcomes focused around this system that tests against being in the RED zone (unacceptable outcome) based on an expectation of being in the GREEN zone (acceptable outcome) and choose the sample size to give high power to reject being in the RED zone if the GREEN zone holds true. Pilot point estimates falling in the RED zone will be statistically non-significant and in the GREEN zone will be significant; the AMBER zone designates potentially acceptable outcome and statistical tests may be significant or non-significant. Results For example, in relation to treatment fidelity, if we assume the upper boundary of the RED zone is 50% and the lower boundary of the GREEN zone is 75% (designating unacceptable and acceptable treatment fidelity, respectively), the sample size required for analysis given 90% power and one-sided 5% alpha would be around n = 34 (intervention group alone). Observed treatment fidelity in the range of 0–17 participants (0–50%) will fall into the RED zone and be statistically non-significant, 18–25 (51–74%) fall into AMBER and may or may not be significant and 26–34 (75–100%) fall into GREEN and will be significant indicating acceptable fidelity. Discussion In general, several key process outcomes are assessed for progression to a main trial; a composite approach would require appraising the rules of progression across all these outcomes. This methodology provides a formal framework for hypothesis testing and sample size indication around process outcome evaluation for pilot RCTs.

Determining sample size for progression criteria for pragmatic pilot RCTs: The Hypothesis test Strikes Back!

Background The current CONSORT guidelines for reporting pilot trials do not recommend hypothesis testing of clinical outcomes on the basis that a pilot trial is under-powered to detect such differences and this is the aim of the main trial. It states that primary evaluation should focus on descriptive analysis of feasibility/process outcomes (e.g. recruitment, adherence, treatment fidelity). Whilst the argument for not testing clinical outcomes is justifiable, the same does not necessarily apply to feasibility/process outcomes, where differences may be large and detectable with small samples. Moreover, there remains much ambiguity around sample size for pilot trials. Methods Many pilot trials adopt a ‘traffic light’ system for evaluating progression to the main trial determined by a set of criteria set up a priori. We construct a hypothesis-testing approach for binary feasibility outcomes focused around this system that tests against being in the RED zone (unacceptable outcome) based on an expectation of being in the GREEN zone (acceptable outcome) and choose the sample size to give high power to reject being in the RED zone if the GREEN zone holds true. Pilot point estimates falling in the RED zone will be statistically non-significant and in the GREEN zone will be significant; the AMBER zone designates potentially acceptable outcome and statistical tests may be significant or non-significant.Results For example, in relation to treatment fidelity, if we assume the upper boundary of the RED zone is 50% and the lower boundary of the GREEN zone is 75% (designating unacceptable and acceptable treatment fidelity, respectively), the sample size required for analysis given 90% power and one-sided 5% alpha would be around n=34 (intervention group alone). Observed treatment fidelity in the range of 0-17 participants (0-50%) will fall into the RED zone and be statistically non-significant; 18-25 (51-74%) fall into AMBER and may or may not be significant; 26-34 (75-100%) fall into GREEN and will be significant indicating acceptable fidelity.Discussion In general, several key process outcomes are assessed for progression to a main trial; a composite approach would require appraising the rules of progression across all these outcomes. This methodology provides a formal framework for hypothesis-testing and sample size indication around process outcome evaluation for pilot RCTs.

Determining sample size for progression criteria for pragmatic pilot RCTs: The Hypothesis test Strikes Back!

BackgroundThe current CONSORT guidelines for reporting pilot trials do not recommend hypothesis testing of clinical outcomes on the basis that a pilot trial is under-powered to detect such differences and this is the aim of the main trial. It states that primary evaluation should focus on descriptive analysis of feasibility/process outcomes (e.g. recruitment, adherence, treatment fidelity). Whilst the argument for not testing clinical outcomes is justifiable, the same does not necessarily apply to feasibility/process outcomes, where differences may be large and detectable with small samples. Moreover, there remains much ambiguity around sample size for pilot trials. MethodsMany pilot trials adopt a ‘traffic light’ system for evaluating progression to the main trial determined by a set of criteria set up a priori. We construct a hypothesis-testing approach for binary feasibility outcomes focused around this system that tests against being in the RED zone (unacceptable outcome) based on an expectation of being in the GREEN zone (acceptable outcome) and choose the sample size to give high power to reject being in the RED zone if the GREEN zone holds true. Pilot point estimates falling in the RED zone will be statistically non-significant and in the GREEN zone will be significant; the AMBER zone designates potentially acceptable outcome and statistical tests may be significant or non-significant.ResultsFor example, in relation to treatment fidelity, if we assume the upper boundary of the RED zone is 50% and the lower boundary of the GREEN zone is 75% (designating unacceptable and acceptable treatment fidelity, respectively), the sample size required for analysis given 90% power and one-sided 5% alpha would be around n=35 (intervention group alone). Observed treatment fidelity in the range of 0-17 participants (0-50%) will fall into the RED zone and be statistically non-significant; 18-26 (51-74%) fall into AMBER and may or may not be significant; 27-35 (75-100%) fall into GREEN and will be significant indicating acceptable fidelity.DiscussionIn general, several key process outcomes are assessed for progression to a main trial; a composite approach would require appraising the rules of progression across all these outcomes. This methodology provides a formal framework for hypothesis-testing and sample size indication around process outcome evaluation for pilot RCTs.

Liver Transplantation for Colorectal Liver Metastasis

Purpose of Review Accumulating evidence suggest that selected patients with nonresectable liver only metastases from colorectal cancer can be offered liver transplantation with acceptable outcome. This review provides an update on the scientific literature. Recent Findings The SECA-I study showed an estimated 5-year survival of 60% in a heterogenous patient population and guided the development of the first clinical selection criteria. In the sequel SECA-II trial, an estimated 5-year survival of 83% was obtained. A recent study shows that an Oslo score of 0–2, a metabolic tumor volume below 70 cm3 on PET-CT or Fong score of 0–2 at time of listing, can stratify patients with superior survival. Recurrence is common, but about 70% are slow-growing lung metastases, whereof the majority are resectable. Summary Liver transplantation for colorectal liver metastasis is an option in highly selected patients. Futile use of grafts can be avoided by applying stringent selection criteria.